K220924 is an FDA 510(k) clearance for the Elecsys HSV-2 IgG (08948887160). This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II - Special Controls, product code MYF).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 12, 2022, 195 days after receiving the submission on March 31, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K220924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2022 |
| Decision Date | October 12, 2022 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |